[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615053":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":59,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":18,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","ACTIVE_COMPARATOR","Thirty five patients will receive glutamine in a dose of 6 g \u002Fm2 twice daily (up to a maximum of 10 g\u002Fdose) for forteen consecutive days starting from induction and forteen days starting from d1 of continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007)",[13],"Drug: Glutamine (Pharmacological doses)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care arm","NO_INTERVENTION","the usual standard of care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Glutamine (Pharmacological doses)","glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"nihal hussien aly mostafa, assistant professsor of pediat","CONTACT","+201001053961","nihal.hussien.ali@gmail.com",[32],{"facility":5,"status":18,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cairo","Cairo Governorate","11517","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.24967,30.06263,{"lat":42,"lon":41},[45,49,51,53,55,57],{"name":46,"role":28,"phone":47,"phoneExt":18,"email":48},"nihal hussien aly mostafa, MD of pediatrics","0224175103","NIHAL.HUSSIEN.ALI@GMAIL.COM",{"name":50,"role":28,"phone":18,"phoneExt":18,"email":18},"fatma soliman ebeid, MD of pediatrics",{"name":50,"role":52,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":54,"role":52,"phone":18,"phoneExt":18,"email":18},"iman ahmed ragab, MD of pediatrics",{"name":56,"role":52,"phone":18,"phoneExt":18,"email":18},"salwa mostafa abdel kader, md of pediatrics",{"name":58,"role":52,"phone":18,"phoneExt":18,"email":18},"marwa waheed tolba, md of pediatrics",{"type":60,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100615053","phase-3-glutamine-for-the-prophylaxis-of-vincristine-induced-neuropathy-in-children-and-adolescents-with-cancer-100615053",false,"NCT07287592","Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.","Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer. A Single Center Study","Inclusion Criteria:\n\n1. No sex predilection.\n2. Age: 6 years to 18 years\n3. Children and adolescents diagnosed with hematological malignancy or solid tumors expected to receive a cumulative dose of 6 mg\u002Fm2 of VCR over a 12 week period (or \\>6 mg\u002Fm2 if individual VCR doses were capped at 2 mg) according to their primary cancer treatment protocol\n4. Patients with score less than 5 on pediatric modified total neuropathy scale at Time 0\n\nExclusion Criteria:\n\n1. Patients with CNS tumors\n2. Patients with focal neurologic findings or CNS metastasis Patients with premorbid developmental disorders, neuromuscular disorders or diabetes mellitus Patients with recurrent disease already exposed to \\>8 mg\u002Fm2 of VCR Patients with score more than 5 on pediatric modified total neuropathy scale","ALL","6 Years","18 Years",{"count":72,"type":73},70,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not.\n\nParticipants will:\n\nreceive glutamine in a dose of 6 g \u002Fm2 twice daily (up to a maximum of 10 g\u002Fdose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation .\n\n• Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event",[79,80],"Neuropathy","Cancer",[82,83,84],"vincristine","cancer","neuropathy","NOT_YET_RECRUITING","2025-12-14",{"date":88,"type":89},"2025-12-17","ACTUAL",{"date":91,"type":73},"2025-12-30",{"date":93,"type":73},"2027-04-30",{"name":5,"class":6},1]